Medical Qualification

With unequaled experience, Mikron is the partner best suited to assist you – from design and approval to the end of your product’s life cycle. We offer a full range of consulting services and are committed to ensuring that the final result exceeds your expectations.

Your Benefits

Qualification Process

Brochures

Documentation harmonized for the United States, European and Asian markets.

The documents provided are approved and ready for use during the next stage of qualification.

The basic machine – hardware and software – has been pre-validated according to GAMP 5 and is 21 CFR (part 11) compatible. Over 150 tests have already been successfully tested on your machine, and new tests can focus on the quality-critical system elements.

The experts at Mikron are at your side for each step in the project. You can therefor reduce the need for external consultants.

100 years of experience in high-quality manufacturing.

Contact us

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